But Wait…There’s More! (Part 1)

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.

As widely reported, President Donald Trump signed the FDA Reauthorization Act into law on August 18th. As part of this law, the Food and Drug Administration (FDA) is directed to create and regulate a new category of hearing aids that can be sold over-the-counter (OTC) to individuals with mild to moderate hearing loss. If you think President Trump’s signature brings down the curtain on the OTC hearing aids, don’t worry folks – that was just the first act; the second act is just beginning.

Act Two Begins

In my previous post, I outlined the next steps in this process, having assumed the legislation was going to be passed by the Senate and the bill signed by the President. The next step involves the publication of a set of FDA rules which will specify how the law will be implemented including requirements for labeling, limits for gain and output, and user warnings, among other provisions. By law, the FDA will have up to 3 years to publish their proposed directive in the Federal Register after which the public will have an opportunity to comment prior to the issuance of the final rule.

It’s highly unlikely that the FDA will require three years to do this since they’re already at work on the regulation; indeed, a draft signaling some of FDA’s thinking was unveiled and discussed at the June 9th, 2017 National Academies of Sciences, Engineering and Medicine (NASEM) stakeholders meeting.

In response to that draft, the Hearing Industries Association (HIA) recently sent a letter to FDA’s Office of Device Evaluation, the office primarily responsible for promulgating the OTC hearing aid rules. HIA’s recommendations to FDA covers three major areas:

1. regulatory overview
2. labeling
3. specifications/standards

The full letter can be found here. What will follow in this and subsequent posts is a high-level, three-part review of this letter.

Regulatory Review

Today’s post will focus on HIA’s recommendations concerning regulatory overview of the OTC devices. Parts 2 and 3 will focus on the labeling and the specifications and standards respectively. In the interest of full disclosure, I am a consultant to the HIA and contributed to the Association’s letter to the FDA.

Is It Safe?

HIA is concerned that the fact that these new hearing aids can be sold directly to the consumer will lead to a relaxing of regulations that presently govern hearing aids sold through conventional channels. In fact, the risks inherent in the use of a hearing aid are not reduced by simply changing to an OTC distribution method – if anything, the use of an OTC model raises new questions about product safety and effectiveness.

As a result, it is critically important that OTC hearing aids be subject to the same regulatory oversight as traditional hearing aids including, in particular, OTC hearing aids with wireless features. As noted during the NASEM discussion on June 9th, the risks of interference with pacemakers and other devices do not disappear merely because a hearing aid is distributed OTC. HIA therefore supports requiring FDA marketing applications (i.e., 510(k)s)  for OTC hearing aids prior to initial sale by a manufacturer.

Is It Sufficient? Efficient?

Furthermore, OTC devices should be required to comply with FDA’s Quality System Regulation (“QSR”) for medical devices. This would ensure proper design controls, the maintenance of required documentation, supplier controls, and complaint handling. The consumer electronics industry has argued that the general quality standards for consumer products will be sufficient to ensure the safety and effectiveness of OTCs.

HIA disagrees with this position. Whether provided through a professional or direct purchase, hearing aids are medical devices and need to be regulated as such. Additionally, in the interests of consumer safety and device effectiveness, HIA encourages the application of ANSI Standard 3.22 to OTC hearing aids, as is currently required of traditionally distributed hearing aids.

Regulatory Remedies

HIA encourages FDA to adopt additional requirements specific to OTC hearing aids to ensure their safety and effectiveness. This includes:

• The adoption of a self-assessment test. Consumers must have a proven, verified, and validated tool to ascertain their own levels of hearing loss (as the sale of OTCs will be restricted to consumers with mild to moderate hearing loss).
• Additionally, since the law prohibits any rule or provision that would interfere with the direct purchase of OTCs, FDA should require evidence demonstrating that consumers can use OTC hearing aids safely and effectively without professional assistance.

  There is considerable precedence for this policy. For example, FDA required these types of clinical evidence of consumer usability determinations when clearing the Icare Home Tonometer for OTC glaucoma monitoring rather than by prescription. There, FDA reviewed human factors testing on the product design and labeling, including usability tests and actual-use validation tests to demonstrate the safety and effectiveness of the product by the intended user population in the intended use environments. This included training, self-tests, and certifications by a professional to ensure that self-testing was performed adequately. Similarly, for an acne light therapy mask switching from prescription use to OTC, the sponsor performed usability and self-selection studies to demonstrate that the intended users of the device could successfully follow the instructions and use the device as intended. A 12-week clinical study assessing safety and efficacy of the device was also performed.

• Finally, consumer electronic products like personal sound amplification products (PSAPs) which are not considered medical devices per FDA, should be barred from making hearing loss treatment claims. Permitting consumer electronic products to be marketed to treat hearing loss would be akin to a complete deregulation of the industry and would have broader ramifications for the entire device regulatory regime. There is a significant distinction between a PSAP and hearing aid, OTC or otherwise, due to the different intended uses. A change in distribution method should not change this established framework. Consequently, HIA strongly encourages FDA to review and finalize its 2013 Draft PSAP Guidance to clarify these distinctions as part of any OTC hearing aid rulemaking process.

Next time: HIA’s recommendations concerning labeling requirements for OTC hearing aids.

Harvey Abrams PhD

Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice.  Dr. Abrams can be reached at[email protected]

Images from Ross Land/Getty and askideas